NeoStem Reports Second Data Safety Monitoring Board Review: Continue With PreSERVE AMI Phase 2 Trial as Planned Mar 7 2013
New York, March 7, 2013 - NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the fast growing cell therapy market, today announced that, on March 6, 2013, it received approval to continue the PreSERVE AMI Phase 2 clinical trial following its second interim data and safety review by the Data Safety Monitoring Board (DSMB). The PreSERVE trial of AMR-001 is a Phase 2, randomized, placebo controlled, double-blind study designed to treat 160 patients and is approved by the FDA to enroll up to 180 patients. AMR-001 is being evaluated for the prevention of major adverse cardiac events following acute myocardial infarction (AMI). Patient enrollment for the PreSERVE trial began in January 2012, and NeoStem anticipates completing enrollment in 2013 with initial data readout six to eight months later.
"We are pleased that the second external review of our Phase 2 trial data confirms that there are no safety signals that would preclude the trial from continuing as planned," said Andrew L. Pecora, M.D., FACP, CPE, Chief Medical Officer of NeoStem. "We've learned through our principal investigators that the collection of stem cells and administration of AMR-001 is relatively straightforward for the treatment of patients within 11 days following an acute MI. Thus, we are confident that physicians will be in a position to realize the potential of this technology in the real clinical setting."
"The results of our Phase 1 trial, and the large and growing body of scientific data and clinical experience, support the continued development of AMR-001," said Jonathan Sackner-Bernstein, M.D., F.A.C.C., Vice President of Clinical Development and Regulatory Affairs of NeoStem. "In early 2012, the Cochrane Collaboration published a comprehensive review of clinical trials that concluded that safety and efficacy is likely to be observed with the use of autologous bone marrow derived stem cells as treatment for acute ST segment elevation of myocardial infarction. The Cochrane Review's rigorous analysis of data from over 1,700 patients, including Amorcyte's Phase 1 trial, highlighted the safety and likely benefit of autologous bone marrow hematopoietic stem cell therapy for patients following a heart attack. The Review reported that this therapeutic approach preserves heart muscle, lowers the risk of further heart attacks, reduces the need for additional invasive procedures, and prevents deaths from cardiovascular disease."
About NeoStem, Inc.
NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.
Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.
For more information on NeoStem, please visit www.neostem.com.
Forward-Looking Statements for NeoStem, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.